Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K910142 |
Device Name |
SPARK KIT(R), MODIFICATION |
Applicant |
LYPHOMED, INC. |
2045 NORTH CORNELL AVE. |
MELROSE PARK,
IL
60160
|
|
Applicant Contact |
DONALD E BAKER |
Correspondent |
LYPHOMED, INC. |
2045 NORTH CORNELL AVE. |
MELROSE PARK,
IL
60160
|
|
Correspondent Contact |
DONALD E BAKER |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 01/14/1991 |
Decision Date | 05/14/1991 |
Decision |
Substantially Equivalent - Kit With Drugs
(SEKD) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|